Methods of Information in Medicine, Table of Contents Methods Inf Med 2015; 54(03): 291-292DOI: 10.3414/ME15-05-0005 Communications Editor´s Corner Schattauer GmbH To Be or not to Be a Medical Device: Is the Regulatory Framework a Safety Rope or a Fetter? R. Röhrig 1 Carl von Ossietzky University, Oldenburg, Germany › Author Affiliations Recommend Article Abstract Buy Article Keywords KeywordsSoftware as a medical device - stand alone software - medical devices/legislation and jurisprudence - medical devices/standards - regulatory affairs Full Text References References 1 US. Food and Drug Administration (FDA). Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff. 2015 [cited 2015 Apr 4]. Available from: URL www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM401996.pdf. 2 U.S. Food and Drug Administration (FDA). Mobile Medical Applications - Guidance for Indus-try and Food and Drug Administration Staff. 2015 [cited 2015 Apr 4]. Available from: URL www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf. 3 Magrabi F, Ong M, Runciman W, Coiera E. An analysis of computer-related patient safety incidents to inform the development of a classification. J Am Med Inform Assoc 2010; 17 (06) 663-670. 4 Magrabi F, Ong M, Runciman W, Coiera E. Patient safety problems associated with heathcare information technology: an analysis of adverse events reported to the US Food and Drug Administration. AMIA Annu Symp Proc 2011 2011; 853-857.
